Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00694889
First received: June 9, 2008
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.


Condition Intervention Phase
Schizophrenia
Behavioral: Neuroadaptive cognitive training
Behavioral: Computer games
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Cognitive Performance, as measured by a neuropsychological battery [ Time Frame: Measured at Baseline, Week 8, and 6 Month Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom profile, as measured by clinical interviews [ Time Frame: Measured at Baseline, Week 8, and 6 Month Follow-Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Study Completion Date: January 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will use commercially available computer games.
Behavioral: Computer games
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
Experimental: 2
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
Active Comparator: 3
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.

Detailed Description:

Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.

Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
  • First psychotic episode within the last 3 years
  • Good general physical health
  • Age between 12-35
  • Is fluent and proficient in the English language
  • Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
  • Minors must have parental/legal guardian consent to participate

Exclusion Criteria:

  • Any neurological disorder
  • History of psychoactive substance abuse in the past 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694889

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Stanley Medical Research Institute
Investigators
Principal Investigator: Sophia Vinogradov, MD University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
Study Director: Rachel Loewy, PhD University of California, San Francisco
Study Director: Cameron Carter, MD University of California, Davis
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00694889     History of Changes
Other Study ID Numbers: 06TAF-972
Study First Received: June 9, 2008
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Psychosis
First Episode
Schizophrenia
Cognitive Remediation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014